ANDA 211783

CHEMO RESEARCH SL

FDA Drug Application

Application #211783

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 211783

CHEMO RESEARCH SL

Marketing Status

• Prescription: 001

Application Products

001

GEL;TRANSDERMAL

0.1%

0

ESTRADIOL

ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CHEMO RESEARCH SL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211783
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.1%","dosageForm":"GEL;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-10
        )

)